NCT03233646

Retinal Imaging in Neurodegenerative Disease

Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.

Detailed description

Using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. The investigators propose to develop and evaluate imaging biomarkers from OCT, OCTA, and UWF fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals. The investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. Using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using OCT and OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases. This study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging. The protocol for this study was amended and the record was updated accordingly.

Conditions

• Alzheimer's Disease
• Mild Cognitive Impairment
• Parkinson's Disease
• Multiple Sclerosis
• Huntington Disease
• Lewy Body Dementia
• Frontotemporal Dementia
• Amyotrophic Lateral Sclerosis (ALS)
• APOE-4 Positive
• Traumatic Brain Injury
• Concussion
• Post-Traumatic Stress Disorder
• Down Syndrome
• Neuro-Degenerative Disease
• Normal Cognition

Interventions

Type	Name	Description
DEVICE	Retinal and Choroidal Imaging	Non-invasive OCT, OCTA, and UWF fundus photography of retina

Timeline

• Start date: 2017-07-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2017-07-28
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study